Method of repairing a defective heart valve

ABSTRACT

A method of repairing a defective heart valve is disclosed comprising directing an implant delivery catheter to form a first curve of the implant delivery catheter around chordae of the heart valve on a ventricular side of the heart valve, inserting the implant delivery catheter through the heart valve to an atrial side thereof, forming a second curve of the delivery catheter along an annulus of the heart valve on the atrial side, and ejecting an annuloplasty implant from the delivery catheter while retracting the delivery catheter such that the annuloplasty implant is arranged along the first and second curve on the ventricular and atrial side.

RELATED APPLICATIONS

This application is a continuation of and claims priority to U.S. Pat.No. 15,627,385 filed Jun. 19, 2017, entitled Method Of Repairing ADefective Heart Valve, which is hereby incorporated herein by referencein its entirety.

FIELD OF THE INVENTION

This invention pertains in general to the field of cardiac valve repair.More particularly the invention relates to a method of repairing adefective heart valve.

BACKGROUND OF THE INVENTION

Diseased mitral and tricuspid valves frequently need replacement orrepair. The mitral and tricuspid valve leaflets or supporting chordaemay degenerate and weaken or the annulus may dilate leading to valveleak. Mitral and tricuspid valve replacement and repair are frequentlyperformed with aid of an annuloplasty ring, used to reduce the diameterof the annulus, or modify the geometry of the annulus in any other way,or aid as a generally supporting structure during the valve replacementor repair procedure. Such annuloplasty rings or other annuloplastyimplants are put into position and fixated to the tissue by variousimplantation procedures.

It is known that cardiac valve repair is a time critical and difficultprocedure. Although minimally invasive catheter-based procedures areemployed today, known solutions are associated with lengthy proceduresthat depend heavily on the skills of the medical staff. Besides from theimmediate difficulties, e.g. associated with the delivery, placement andfixation of the annuloplasty implant, the occurrence of complicationsarising in the long-term follow-up can not be neglected. Frequentinterventions may thus be required to ensure correct functioning overtime, which will also impact the recovery and health of the patient.Another problem is to ensure that a significant part of the annulus isreshaped while providing for atraumatic engagement with the anatomy.

A further problem is the cumbersome placement of annuloplasty implantsdue to interference from the surrounding anatomy such as the chordae ofthe valve leaflets. This typically results in entanglement of theimplant into the chordae, and time-consuming repositioning may berequired. Generally, it is a problem with previous solutions that oncethe implant is ejected from the delivery catheter, it is difficult tofully control position of the implant since the amount of control of thedistal parts ejected is reduced.

The above problems may have dire consequences for the patient and thehealth care system. Patient risk is increased.

Hence, an improved method of repairing a defective heart valve would beadvantageous and in particular allowing for avoiding more of theabove-mentioned problems and compromises, and in particular allowing forfacilitated positioning and fixation of an annuloplasty implant whilereducing the time of the intervention, and providing for increasedpatient safety.

OBJECTS AND SUMMARY OF THE INVENTION

Accordingly, examples of the present invention preferably seeks tomitigate, alleviate or eliminate one or more deficiencies, disadvantagesor issues in the art, such as the above-identified, singly or in anycombination by providing a device according to the appended patentclaims.

According to a first aspect a method of repairing a defective heartvalve is provided comprising directing an implant delivery catheter toform a first curve of the implant delivery catheter around chordae ofthe heart valve on a ventricular side of the heart valve, inserting theimplant delivery catheter through the heart valve to an atrial sidethereof, forming a second curve of the delivery catheter along anannulus of the heart valve on the atrial side, and ejecting anannuloplasty implant from the delivery catheter while retracting thedelivery catheter such that the annuloplasty implant is arranged alongthe first and second curve on the ventricular and atrial side.

According to a second aspect a method of repairing a defective heartvalve is provided comprising inserting a flexible and removable coronarysinus contractor device into a coronary sinus (CS) adjacent said heartvalve, positioning a proximal expandable portion of the coronary sinuscontractor device against a tissue wall at the entrance of said CS,positioning a distal anchoring portion of the coronary sinus contractordevice inside said CS, temporarily transferring said coronary sinuscontractor to an activated state in which the shape of the annulus ofthe heart valve is modified to a modified shape to be retained by anannuloplasty implant. The method further comprising directing an implantdelivery catheter to the position of the valve, delivering anannuloplasty implant from the implant delivery catheter so that theannuloplasty implant is positioned around the annulus of the valve,fixating said annuloplasty implant to retain said modified shape, andremoving the coronary sinus contractor device.

Further examples of the invention are defined in the dependent claims,wherein features for the second and subsequent aspects of the disclosureare as for the first aspect mutatis mutandis.

Some examples of the disclosure provide for a facilitated positioning ofan annuloplasty implant at a heart valve.

Some examples of the disclosure provide for a facilitated fixation of anannuloplasty implant at a heart valve.

Some examples of the disclosure provide for facilitating resizing theannulus of a heart valve.

Some examples of the disclosure provide for facilitating resizing theannulus of a heart valve before positioning an annuloplasty implant atthe heart valve.

Some examples of the disclosure provide for a less time consumingimplantation of an annuloplasty implant at a heart valve.

Some examples of the disclosure provide for improved long-termreliability of a remodeled heart valve.

Some examples of the disclosure provide for facilitated guidance of anannuloplasty implant to an annulus of a heart valve.

Some examples of the disclosure provide for a more secure implantationof an annuloplasty implant in narrow anatomies.

Some examples of the disclosure provide for increased steerability ormaneuverability of an annuloplasty implant.

Some examples of the disclosure provide for increased accuracy inpositioning an annuloplasty implant at the annulus and thereby reducingthe risk of complications.

Some examples of the disclosure provide for a reduced risk of damagingthe surrounding tissue or the annuloplasty implant valve during animplantation procedure.

Some examples of the disclosure provide for better ability to repositionan annuloplasty implant.

Some examples of the disclosure provide for avoiding interference of theannuloplasty implant with the chordae of the valve leaflets.

Some examples of the disclosure provide for improved control of theposition of the implant when being delivered from a delivery device.

It should be emphasized that the term “comprises/comprising” when usedin this specification is taken to specify the presence of statedfeatures, integers, steps or components but does not preclude thepresence or addition of one or more other features, integers, steps,components or groups thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of which embodiments ofthe invention are capable of will be apparent and elucidated from thefollowing description of embodiments of the present invention, referencebeing made to the accompanying drawings, in which

FIG. 1 a is a schematic illustration of an arrangement of a deliverydevice and a coronary sinus downsizing device in a method according toone example;

FIG. 1 b is a schematic illustration of an arrangement of a deliverydevice in a method according to one example, where the delivery devicehas been further advanced to form a first curve around chordae of theheart;

FIG. 1 c is a schematic illustration of an arrangement of a deliverydevice in a method according to one example, where the delivery devicehas been further advanced to begin forming a second curve on an atrialside of the heart valve;

FIG. 1 d is a schematic illustration of an arrangement of a deliverydevice in a method according to one example, where the delivery devicehas been further advanced to form a second curve along the annulus ofthe heart valve;

FIG. 1 e is a schematic illustration of an arrangement of a deliverydevice in a method according to one example, where an annuloplastyimplant has been ejected on the atrial side while retracting thedelivery device;

FIG. 1 f is a schematic illustration of an arrangement of a deliverydevice in a method according to one example, where the delivery devicehas been further retracted and the annuloplasty implant contacts theheart valve on the atrial and ventricular side thereof;

FIG. 1 g is a schematic illustration of an arrangement of a deliverydevice in a method according to one example, where the delivery devicehas been further retracted;

FIG. 1 h is a schematic illustration of an arrangement of a deliverydevice in a method according to one example, where the annuloplastyimplant contacts the heart valve on the atrial and ventricular sidethereof in a helix-shaped configuration;

FIG. 1 i is a schematic illustration of an arrangement of a deliverydevice in a method according to one example, where the annuloplastyimplant is fixated by a fastening device;

FIG. 2 a is a schematic illustration of an arrangement of a deliverydevice, an annuloplasty implant and a coronary sinus downsizing devicein a method according to one example;

FIG. 2 b is a schematic illustration of an arrangement of a deliverydevice, an annuloplasty implant and a coronary sinus downsizing devicein a method according to one example, where the annuloplasty implant hasbeen further ejected from the delivery device;

FIG. 2 c is a schematic illustration of an arrangement of a deliverydevice, an annuloplasty implant and a coronary sinus downsizing devicein a method according to one example, where the annuloplasty implant hasbeen partly arranged through a commissure of the heart valve;

FIG. 2 d is a schematic illustration of an arrangement of a deliverydevice, an annuloplasty implant, a coronary sinus downsizing device, anda fastening device in a method according to one example, where fasteningunits are placed on the annuloplasty implant;

FIG. 2 e is a schematic illustration of an arrangement of a deliverydevice, an annuloplasty implant, a coronary sinus downsizing device, anda fastening device in a method according to one example, where fasteningunits are placed on the annuloplasty implant;

FIG. 3 a is a schematic illustration of an arrangement of a deliverydevice, an annuloplasty implant and a coronary sinus downsizing devicein a method according to one example;

FIG. 3 b is a schematic illustration of an arrangement of a deliverydevice, an annuloplasty implant, a coronary sinus downsizing device, anda stabilizing unit in a method according to one example;

FIG. 4 a is a schematic illustration of an arrangement of a deliverydevice, an annuloplasty implant and a coronary sinus downsizing devicein a method according to one example;

FIG. 4 b is a schematic illustration of an arrangement of a deliverydevice, an annuloplasty implant and a coronary sinus downsizing devicein a method according to one example, where the annuloplasty implant hasbeen rotated in the atrium of the heart;

FIG. 4 c is a schematic illustration of an arrangement of a deliverydevice, an annuloplasty implant and a coronary sinus downsizing devicein a method according to one example, where the annuloplasty implant hasbeen positioned on the ventricular- and atrial sides of the heart valve;

FIG. 4 d is a schematic illustration of an arrangement of a deliverydevice, an annuloplasty implant and a coronary sinus downsizing devicein a method according to one example, where the annuloplasty implant hasbeen positioned on the ventricular- and atrial sides of the heart valve;

FIG. 5 a is a schematic illustration of an arrangement of a deliverydevice, an annuloplasty implant and a coronary sinus downsizing devicein a method according to one example;

FIG. 5 b is a schematic illustration of an arrangement of a deliverydevice, an annuloplasty implant and a coronary sinus downsizing devicein a method according to one example, where the annuloplasty implant hasbeen further ejected from the delivery device;

FIG. 6 is a schematic illustration of an arrangement of a deliverydevice, an annuloplasty implant, a coronary sinus downsizing device, anda stabilizing unit in a method according to one example;

FIG. 7 is a flow-chart of a method of repairing a defective heart valveaccording to one example; and

FIG. 8 is a flow-chart of a method of repairing a defective heart valveaccording to one example.

DESCRIPTION OF EMBODIMENTS

Specific embodiments of the invention will now be described withreference to the accompanying drawings. This invention may, however, beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein; rather, these embodiments areprovided so that this disclosure will be thorough and complete, and willfully convey the scope of the invention to those skilled in the art. Theterminology used in the detailed description of the embodimentsillustrated in the accompanying drawings is not intended to be limitingof the invention. In the drawings, like numbers refer to like elements.

The following description focuses on examples applicable to cardiacvalve implants such as annuloplasty rings. However, it will beappreciated that the invention is not limited to this application butmay be applied to many other annuloplasty implants and cardiac valveimplants including for example replacement valves, and other medicalimplantable devices.

A method 300 of repairing a defective heart valve 800 is disclosed. Themethod 300 is schematically illustrated in FIG. 8 , in conjunction withFIGS. 1 a-i . The order in which the steps are described should not beconstrued as limiting, and it is conceivable that the order of the stepsmay be varied depending on the particular procedure. As shown in FIGS. 1a-b , the method 300 comprises directing 302 an implant deliverycatheter 501 to form 303 a first curve 506 of the implant deliverycatheter 501 around the chordae 801 of the heart valve on a ventricularside of the heart valve 800. The heart valve may be the mitral valve,and the ventricle may thus be the left ventricle. The method 300 maycomprise positioning the delivery catheter 501 in the ventricle byaccessing 301 the ventricle through the apex of the heart with anintroducer 500. The delivery catheter 501 may then then be insertedthrough the introducer 500, as illustrated in the example of FIG. 1 a .Alternatively, the method 300 may comprise positioning the deliverycatheter 501 in the ventricle by accessing the ventricle through theaortic valve, or by creating access to the left ventricle through theseptum between the right and left ventricle. Regardless, the method 300comprises forming 303 a first curve 506 of the implant delivery catheter501 around the chordae 801 of the heart valve on a ventricular side ofthe heart valve 800. The delivery catheter 501 may thus be firstnavigated to the ventricular space between the chordae 801 and the heartmuscle, so that the delivery catheter 501 can be curved around thechordae 801 on the ventricular side. The method 300 comprises inserting305 the implant delivery catheter 501 through the heart valve 800 to theatrial side thereof, and forming 307 a second curve 507 of the deliverycatheter 501 along an annulus 802 of the heart valve 800 on the atrialside, which is illustrated in FIGS. 1 c-d . The delivery catheter 501may be advanced such that annulus is followed in a counter-clockwisedirection. In the example of FIG. 1 c , the delivery catheter 501 hasbegun to be inserted through the heart valve 800 to form the secondcurve 507 on the atrial side. Parts of the delivery catheter 501 on theventricular side has been illustrated with dashed lines for clarity ofpresentation. In FIG. 1 d , the delivery catheter 501 has been furtheradvanced through the valve 800, taking e.g. the distal tip 509 of thedelivery catheter 501 as a reference point. The method 300 comprisesejecting 309 an annuloplasty implant 400 from the delivery catheter 501while retracting 310 the delivery catheter 501 such that theannuloplasty implant 400 is arranged along the first and second curve506, 507, on the ventricular and atrial side of the valve. FIG. 1 eillustrates an example where the implant 400 has been ejected and thedelivery catheter 501 has been retracted on the atrial side, along partof the second curve 507, e.g. again comparing the position of the distaltip 509 in FIGS. 1 d-e . The implant 400 is thus abutting the valvetissue on the atrial side. In the example of FIGS. 1 d-e , the implant400 has begun to be ejected when the distal tip 509 of the deliverycatheter 501 has reached the position illustrated in FIG. 1 d , whilesimultaneously retracting the delivery catheter 501. The position of adistal tip 403 of the implant 400 in this example thus correspondssubstantially to the previous position of the distal tip 509 of thedelivery catheter 501. Since the delivery catheter 501 is simultaneouslyretracted along the curvature of the first and second curve 506, 507,when ejecting the implant 400, the positioning of the implant 400 willeffectively correspond to withdrawing the delivery catheter as a sheathpreviously covering the implant 400 which already is arranged along thecurvature provided by the delivery catheter 501 when forming the firstand second curve 506, 507, thereof. Hence, the delivery catheter 501 caneffectively serve as a guide for the implant 400 for the positioningthereof on the ventricular and atrial side, without having to navigatethe implant 400 into the correct position after being ajected from thedelivery catheter 501. This provides for improving the control of thepositioning of the implant 400, since otherwise, as soon as an implantis ejected from a delivery catheter, the amount of control andsteerability on the ejected part is diminished by the decoupling fromthe physical constrain of the catheter. Positioning the implant 400 asdescribed above removes the steerability requirement on the implant 400after being ejected, due to the guiding of the implant 400 to the finalposition, while being fully confined within the delivery catheter 501.This also minimizes the risk of interference with the surroundinganatomy, such as entanglement of the implant 400 with the chordae 801. Amore reliable and secure positioning of the implant 400 at the heartvalve 800 is thus achieved. FIGS. 1 f-g illustrate a further retractionof the delivery catheter 501, i.e. the distal tip 509 thereof is againpositioned on the ventricular side. The implant 400 is thus in contactwith the valve tissue on both the atrial and ventricular side. As withthe delivery catheter 501, the parts of the implant 400 positioned onthe ventricular side are illustrated with dashed lines for clarity ofpresentation. In FIG. 1 h the delivery catheter 501 has been fullyretracted from the valve 800. In the example shown in FIGS. 1 g-h , theimplant 400 has been decoupled from the delivery catheter 501 when thedistal tip 509 thereof reach the position illustrated in FIG. 1 g , thussubstantially corresponding to the position of a proximal end 404 of theimplant 400.

Forming the first curve 506 of the delivery catheter 501 may compriseforming 304 a loop of the delivery catheter around the chordae 801, asillustrated in FIGS. 1 b-c . A majority of, or substantially all of thechordae may be circumflexed by the first curve 506 of the deliverycatheter 501. Inserting the implant delivery catheter 501 through theheart valve 800 may comprise inserting 306 the implant delivery catheterthrough a first commissure 805 of the heart valve 800, as schematicallyillustrated in FIG. 1 c . The first curve 506 and the second curve 507may form a helix shape 508 as further illustrated in e.g. FIG. 1 d . Thefirst and second curve 506, 507, may thus form two continuouslyconnected loops, on opposite sides of the heart valve, being connectedthrough the commissure 805. This provides for achieving an efficientdeployment of an annuloplasty implant 400 around the annulus of thevalve 800, on both the ventricular and atrial sides. Before being loopedaround the chordae 801, the delivery catheter 501 may be navigated to aposition adjacent to a second commissure 805′ of the heart valve 800,opposite the first commissure 805 through which the implant 400 isinserted from the ventricular to the atrial side. The first and secondcommissures 805, 805′, may correspond to the anterior and posteriorcommissures of the mitral valve, respectively.

The annuloplasty implant 400 may have a predefined ring-shape having acurvature corresponding substantially to the first and second curve 506,507, such that, when ejected from the delivery catheter 501, theannuloplasty implant 400 is arranged along the first and second curve506, 507. By having a predefined ring-shape approximating the curvatureof the first and second curves 506, 507, of the delivery catheter 501,the annuloplasty implant 400 may be readily aligned around the heartvalve 800 along the extension of the first and second curves 506, 507,when the implant 400 is ejected and the delivery catheter issimultaneously withdrawn, with a minimum of movement of the implant 400relative to the valve 800 when the delivery catheter 501 is withdrawn. Amore stable and controlled positioning of the implant 400 along theannulus of the heart valve 800 may thus be achieved. The predefinedring-shape of the implant 400 can be determined for example by a heattreatment procedure during manufacturing of the implant 400. When theimplant is confined in the delivery catheter 501, it assumes anelongated configuration, until it is ejected, whereby it assumes thepredefined shape, i.e. the relaxed shape of the shape-memory of thematerial from which the ring is formed.

The predefined ring-shape may be a helix-shaped ring, whereby a firstsupport ring 401 of the helix-shaped ring is positioned on the atrialside and a second support ring 402 of the helix-shaped ring ispositioned on the opposite ventricular side when ejecting theannuloplasty implant 400 from the delivery catheter 501 while retractingthe delivery catheter 501, as illustrated in e.g. FIGS. 1 e-h , with thegradual withdrawal of the delivery catheter 501. The leaflets 803 of thevalve 800 can thereby be pinched between the first and second supportrings 401, 402, providing for a stable fixation of the implant 400 atthe heart valve 800. Arranging the delivery catheter 501 to form ahelix-shaped configuration of the first and second curves 506, 507, onthe ventricular and atrial side is thus particularly advantageous fordeployment of a helix-shaped implant 400, and provides for a facilitatedand improved fixation of a helix-shaped annuloplasty implant 400 at theheart valve 800. It is conceivable however that the delivery catheter501 may be arranged to form differently shaped curves 506, 507, on theventricular and/or atrial side of the valve 800, and that the shape ofthe annuloplasty implant 400 may be varied accordingly. For example, theangle by which the first and/or second curve 506, 507, spans theperiphery of the heart valve may be increased or decreased depending onthe corresponding length of the implant 400.

The method 300 may comprise aligning 308 the first and second curve 506,507, of the delivery catheter 501 generally in the plane of the heartvalve 800 such that the annuloplasty implant 400 is positioned generallyin said plane when retracting the delivery catheter 501. Aligning thedelivery catheter 501 substantially in the plane of the valve 800, i.ethe plane in which the leaflets of the valve extends, provides for afacilitated positioning of the annuloplasty implant 400, with a minimumof repositioning required until the implant 400 extends along theannulus 802 of the valve 800. The curvature of the delivery catheter 501may be adapted by passive or active manipulation thereof. In the formercase, the delivery catheter 501 may be formed of a shape-memory materialthat assumes a predefined shape when releasing a radial compressionforce thereon, such as by pushing the delivery catheter 501 from theintroducer 500 or a separate sheath. Active manipulation may be providedby actuating steering mechanisms of the delivery catheter 501.

The method 300 may comprise inserting 300′ a flexible and removablecoronary sinus contractor device 100 (CS device) into a coronary sinusvessel (CS) adjacent the heart valve 800. Inserting the CS device maycomprise positioning 301′ a proximal expandable portion 101 of the CSdevice against a tissue wall 804 at the entrance of the CS, positioning302′ a distal anchoring portion 102 of the CS device inside the CS, andtemporarily transferring 303′ the CS device to an activated state inwhich the shape of the annulus 802 is modified to a modified shape to beretained by the annuloplasty implant 400. The method 300 may furthercomprise fixating 311′ the annuloplasty implant 400 to retain saidmodified shape, and removing 315′ the CS device 100. The CS device isschematically illustrated in FIG. 1 a , and is also described in furtherdetail below. FIGS. 1 b-l does not include the CS device 100 for clarityof presentation. The shape of the annulus 802 may thus be temporarilymodified while fixating the annuloplasty implant 400, so that thedesired modified shape can be fixated by the annuloplasty implant 400.The method 300 thus provides for an efficient downsizing of the annulus802, so that the leaflets 803 of the heart valve 800 may coapt asintended, while the new shape of the annulus 802 can be reliablymaintained by the improved delivery and control of the annuloplastyimplant 400 as elucidated above.

Fixating the annuloplasty implant 400 to retain said modified shape maycomprise placing 312′ fastening units 601 on the annuloplasty implant400 from a fastening device 600. The fastening device 600 may bedelivered 313′ to the atrial side of the valve 800, as illustrated inFIG. 1 i or the fastening device 600 may be delivered 314 to theventricular side of the valve 800, via e.g. a transapical access, oraccess via the aortic valve or through the septum. The fastening units601 may be sutures, clips, screws, barbs, or other structures configuredto fixate the position of the tissue relative to the implant 400, sothat the modified shape of the annulus can be maintained when the CSdevice 100 is removed. It is further conceivable that the fasteningunits 601 are integrated into the implant 400 and subsequently activatedto be ejected from the implant 400 to pierce the tissue, and fixate theimplant 400 to the tissue.

A further method 200 of repairing a defective heart valve 800 isdisclosed. The method 200 is schematically illustrated in FIG. 7 . Theorder in which the steps are described should not be construed aslimiting, and it is conceivable that the order of the steps may bevaried depending on the particular procedure. The method 200 comprisesinserting 201 a flexible and removable coronary sinus contractor device100 (CS device) into the coronary sinus vessel (CS) adjacent the heartvalve 800. Inserting the CS device comprises positioning 202 a proximalexpandable portion 101 of the CS device against a tissue wall 804 at theentrance of the CS, positioning 203 a distal anchoring portion 102 ofthe CS device inside the CS, and temporarily transferring 204 the CSdevice to an activated state in which the shape of the annulus 802 ofthe heart valve is modified to a modified shape to be retained by anannuloplasty implant 400. The method 200 further comprises directing 206an implant delivery catheter 501 to the position of the valve from theventricular side of the valve, and delivering 207 an annuloplastyimplant 400 from the implant delivery catheter 501 so that theannuloplasty implant 400 is positioned around the annulus of the valve.Positioning the delivery catheter 501 at the valve from the ventricularside should be construed as first positioning the delivery catheter 501in the ventricle of the heart and then positioning the delivery catheter501 at the valve. The heart valve may be the mitral valve, and theventricle may thus be the left ventricle. The method 200 may comprisepositioning the delivery catheter 501 in the ventricle by accessing 205the ventricle through the apex of the heart with an introducer 500. Thedelivery catheter 501 may then then be inserted through the introducer500, as illustrated in the example of FIG. 2 a . Alternatively, themethod 200 may comprise positioning the delivery catheter 501 in theventricle by accessing the ventricle through the aortic valve, or bycreating access to the left ventricle through the septum between theright and left ventricle. The method 200 further comprises fixating 208the annuloplasty implant 400 to retain said modified shape, and removingthe CS device 100. FIG. 2 a schematically illustrates the CS device 100inserted into the CS, and the proximal expandable portion 101 thereofpositioned at the tissue wall 804 at the entrance of the CS. The distalanchoring portion 102 is anchored inside the CS, distally of theproximal expandable portion 101. The CS device 100 is then transferredto an activated state where the shape of the CS vessel is modified.Since the CS lies adjacent the mitral valve and follows a curvaturearound the annulus of the mitral valve, the annulus of the mitral valveis also modified. In this manner the annulus may be downsized, i.e.retracted to assume a smaller cross-section, and/or a reduced diameter,and/or assume an increased radius of curvature, such that the previouslydilated leaflets of the valve may be brought closer together, i.e.co-apt, to restore the function of the valve. FIG. 2 a illustrates adistal end of the introducer 500 being positioned adjacent the heartvalve 800, such as the mitral valve. The implant delivery catheter 501has been pushed out of a distal opening of the introducer 500, and isthereby arranged in the atrium of the heart, adjacent the valve 800. Theimplant 400 has been partly ejected from the implant delivery catheter501 in FIG. 2 a . Turning to FIG. 2 b , the implant 400 has been furtherejected and assumes, in this example, a coil- or helix-shapedconfiguration with a first support ring 401 and a second support ring402, as explained in further detail below. The implant 400 is positionedaround the annulus as seen in FIGS. 1 c-d . In this example, thefirst-and second support rings are positioned on either side of thevalve 800, but it is conceivable that the implant 400 may assumes avariety of shapes, such as a single-loop ring which is continuous, i.e.closed loop, such as D-shaped, or has two free ends, i.e. discontinuous,such as C-shaped. FIG. 3 a illustrates an example where the implant 400has a single ring configuration. FIGS. 1 d-e schematically illustratefixating the implant 400 by a fastening device 600, as explained furtherbelow. The implant 400 retains the modified shape of the annulus, suchthat the leaflets co-apt, and the temporarily fixated CS device can beremoved, as well as the implant delivery catheter 501, the introducer500, and the fastening device 600. It is thus provided for an efficientand reliable procedure to fixate an annuloplasty implant 400 at theannulus of the heart, thanks to the efficient combination of ventricularaccess and delivery of the implant 400 from the ventricular side, andthe annulus modification procedure via the CS vessel. This combinationallows for example improved visibility from the trial side of the valve,since the annulus modification is provided for by the CS device which isin the CS vessel, and the implant 400 is delivered from the ventricularside. This may then advantageously provide for improved control of theentire implantation procedure, due to the enhanced view from the atrialside. The combination of having a re-shaping procedure from the CS andan annuloplasty implant 400 delivered from the ventricular side thusprovides for an efficient synergy also due to the fact that it'spossible to provide for the maximum benefit from the efficientdownsizing procedure of the annulus by the CS device because of thefacilitated delivery and positioning of the implant 400 via theventricular access. The improved control and reliability of theprocedure also provides for enhancing the adaptability of the procedureto varying anatomies of the heart and the heart valve 800, e.g. such asparticularly narrow or otherwise abnormal anatomies that would otherwisebe impossible due treat.

Delivering the annuloplasty implant 400 from the implant deliverycatheter 501 may thus comprise ejecting 209 the annuloplasty implant 400from the delivery catheter 501 whereby it assumes a predefinedring-shape above the heart valve 800 in the atrium of the heart. Thepredefined ring-shape of the implant 400 can be determined for exampleby a heat treatment procedure during manufacturing of the implant 400.When the ring is confined in the delivery catheter 501, it assumes anelongated configuration, until it is ejected, whereby it assumes thepredefined shape, i.e. the relaxed shape of the shape-memory of thematerial from which the ring is formed.

As mentioned in relation to FIGS. 1 b-e , the predefined ring-shape maybe a helix-shaped ring. The method 200 may comprise rotating andretracting 210 the delivery catheter 501 such that the helix-shaped ringis rotated through the valve 800 and a first support ring 401 of thehelix-shaped ring is positioned on an atrial side of the valve 800 and asecond support ring 402 is positioned on the opposite ventricular sideof the valve 800. The leaflets 803 of the valve 800 can thereby bepinched between the first and second support rings 401, 402. FIG. 2 billustrate the first- and second rings 401, 402, positioned in theatrium, whereas in FIG. 2 c the delivery catheter 501 has been rotatedand retracted such that the free end of the second support ring 402 hasbeen inserted in the commissure of the valve 800 and subsequentlyfurther rotated so that approximately the entire second support ring 402is positioned on the ventricular side of the valve 800. The shape of theannulus which has been modified by the CS device 100 can thus beefficiently retained by the pinching effect between the first and secondsupport rings 401, 402. FIGS. 4 b-c illustrate another example where thefirst and second support rings 401, 402, are rotated into place onopposite sides of the valve 800, in this case around rotational axis503′ of the delivery catheter 501.

The method 200 may comprise aligning 211 a curvature of a distal portion502 of the delivery catheter 501 such that the annuloplasty implant 400is positioned generally in the plane of the valve 800 when ejected fromthe delivery catheter 501. FIG. 2 b illustrates a curvature of thedistal portion 502 of the delivery catheter 501 that is aligned so thatthe ring-shaped implant 400 is ejected with a desired angle in relationto the plane in which the valve 800 extends. This provides forfacilitating insertion of the implant 400 into the valve 800 so that thefirst and second rings 401, 402, are positioned on either side of thevalve leaflets. Also in the case of having a single-ring implant 400, asillustrated in FIG. 3 a , having a determined curvature, such as alignedapproximately in the plane of the valve 800, will facilitate positioningof the implant 400 around the annulus. The curvature of the distalportion 502 may be adapted to depending on the particular procedure, thesize of the surrounding anatomy, and on the shape of the implant 400.The curvature may be adapted by passive or active manipulation of thedistal portion 502. In the former case, the distal portion 502 may beformed of a shape-memory material that assumes a predefined shape whenreleasing a radial compression force thereon, such as by pushing thedistal portion 502 out from the introducer 500 or a separate sheath.Active manipulation may be provided by actuating steering mechanisms ofthe delivery catheter 501.

The method 200 may comprise rotating 212 the annuloplasty implant 400 inthe atrium, after being ejected from the delivery catheter 501, bypivoting an actuator 503 at a distal portion 502 of the deliverycatheter 501, to align the annuloplasty implant 400 generally in theplane of the valve 800, as illustrated in FIGS. 4 a-b . When firstejecting the implant 400 in the atrium, it may assume a configuration asillustrated in FIG. 4 a . I.e. the implant 400 assumes a ring-shape thatspans a plane which forms an angle with the plane in which the valve 800extends, e.g. such an approximately perpendicular angle, as illustratedin FIG. 4 a . In this case the implant 400 is helix-shaped, but it isalso conceivable that the implant 400 may assume any other shape such assingle-loop D- or C-shape, as described above. The actuator 503 may thuspivot around rotational axis 503″ to adjust the angle of the implant 400relative the plane of the valve 800. In FIG. 4 b , the implant 400 hasbeen pivoted so that the plane in which the implant extends isapproximately parallel with the plane of the valve 800. This providesfor facilitating delivery of the implant 400 into the atrium, i.e. sinceit can be ejected from the delivery catheter 501 in the longitudinaldirection of the catheter, as seen in FIG. 4 a , while beingsubsequently pivoted to facilitate the positioning at the annulus. Andin the case of having a helix-shaped implant, the first and secondsupport rings 401, 402, may be rotated further into place as illustratedin FIG. 4 c , by rotation around the longitudinal axis 503′ of thedelivery catheter 501. Rotational axis 503″ may thus be substantiallyperpendicular to the longitudinal axis 503′. Thus, the implantation ofthe implant 400 at the annulus is facilitated by the added degree ofcontrol provided.

Although the examples discussed above describe ejection of the implantin the atrium of the heart, it is conceivable that the method 200 maycomprise ejecting 213 the annuloplasty implant 400 from the deliverycatheter 501 in the ventricle of the heart, and positioning 214 theannuloplasty implant 400 at the valve 800 from a ventricular side of thevalve 800. The delivery catheter 501 may thus be positioned below thevalve 800, in the ventricle, and a helix-shaped implant 400 may beejected through one of the commissures so that the first support ring401 is positioned on the atrial side, and the second support ring ispositioned on the ventricular side.

Fixating the annuloplasty implant 400 to retain the modified shapeprovided by the CS device 100 may comprise placing 215 fastening units601 on the annuloplasty implant 400 from a fastening device 600. Thefastening device 600 may be delivered 216 to the atrial side of thevalve 800, as illustrated in FIG. 2 d , or the fastening device 600 maybe delivered 217 to the ventricular side of the valve 800, asillustrated in FIG. 2 e , via e.g. a transapical access, or access viathe aortic valve or through the septum. The fastening units 601 may besutures, clips, screws, barbs, or other structures configured to fixatethe position of the tissue relative to the implant 400, so that themodified shape of the annulus can be maintained when the CS device isremoved. It is further conceivable that the fastening units 601 areintegrated into the implant 400 and subsequently activated to be ejectedfrom the implant 400 to pierce the tissue, and fixate the implant 400 tothe tissue.

The method 200 may comprise guiding 218 the annuloplasty implant 400with a stabilizing unit 700 arranged in apposition with the annuloplastyimplant 400 while positioning the annuloplasty implant 400 at theannulus of the heart valve 800, as schematically illustrated in FIGS. 3and 6 . This may advantageously provide for increased control of theimplantation procedure, to make the implantation more reliable and/orcompleted in less amount of time. The stabilization unit 700 may thus beconfigured to guide the implant 400 by exerting a correcting forceagainst the implant 400 while positioning the latter at the annulus. Thecorrecting force may be a pulling, pushing, or torqueing force, thatdirects the implant 400 in a desired direction.

The stabilizing unit 700 may be positioned 219 at the commissures of theheart and extending at least partly into the atrium of the heart, asillustrated in FIG. 3 b . Placing the stabilizing unit 700 at thecommissures efficiently anchors the stabilizing unit 700 into position,so that a reliable guiding of the implant 400 can be achieved. Byextending in to the atrium, the stabilizing unit 700 can be arranged toguide the implant 400 while it is ejected into the atrium from thedelivery catheter 501 as illustrated in FIG. 3 b . The stabilizing unit700 may comprise further guiding elements configure to slide against theimplant 400 such as wires forming apertures or C-shaped elements thatengage the implant 400 (not shown) to facilitate the guiding.

The stabilizing unit 700 may comprise a second delivery wire 504 that ismovable relative the delivery catheter 501 in the longitudinal directionthereof, as illustrated in FIGS. 5 a-b . The method 200 may compriseejecting 220 the annuloplasty implant 400 from the delivery catheter 501in the atrium of the heart while fixating 221 the position of a portionof the annuloplasty implant being connected to a distal portion 505 ofthe second delivery wire 504, as schematically illustrated in FIG. 5 a .The position if the implant 400 relative to the valve 800 can thus beeffectively controlled. The second delivery wire 504 may be movedrelative the delivery catheter 501 to arrange the implant 400 as desiredrelative to the valve 800 during the procedure. It is conceivable thatthe implant 400 is releasably locked to the second delivery wire 504, sothat the implant 400 is released when assuming the correct position.This also provides for controlling the position of the free end of theimplant 400 that otherwise may cause trauma to the atrium, or ventricle,when ejected from the delivery catheter 501.

Thus, the method 200 may comprise ejecting and positioning 222 at leasta first support ring 401 of the annuloplasty implant around the annuluson the atrial side of the valve while fixating the position of a portionof the first support ring 401 to the distal portion of the seconddelivery wire 504, as illustrated in FIG. 5 b.

The method 200 may comprise positioning 223 the stabilizing unit 700 inthe ventricle of the heart, and guiding 224 the annuloplasty implant 400through an aperture 701 in a distal portion of the stabilizing unit 700,while ejecting 225 the annuloplasty implant 400 from the deliverycatheter in the atrium, to guide the annuloplasty implant 400 on theventricular side of the heart valve, as illustrated in FIG. 6 . This mayprovide for facilitating the positioning of the implant on theventricular side of the valve since it may be easier to steer theimplant to the ventricular side without having to rotate the implantthrough the commissures. An aperture 701 or any other structureconfigured to steer the implant 400, such as a wire forming ahook-shape, may be used as a guiding element.

The method 200 may comprise positioning 226 at least a first supportring 401 of the annuloplasty implant around the annulus on the atrialside of the valve while the stabilizing unit guides 227 a second supportring 402 of the annuloplasty implant around the annulus on theventricular side of the valve. The method thus provides for afacilitated positioning of a helix-shaped implant on either sides of thevalve leaflets, as illustrated in FIG. 6 .

Temporarily transferring the coronary sinus contractor device (CSdevice) 100 to an activated state may comprise moving 228 the distalanchoring portion 102 in a longitudinal direction of the CS device toreduce the distance between the distal anchoring portion 102 and theproximal expandable portion 101. As the length of the CS device isreduced between the two anchoring sections, the shape of the CS vessel,and thereby the annulus, is modified, to provide the downsizing effectso that the diseased leaflets can co-apt. The combination of reducingthe length CS device and having a proximal expandable portion 101 thatefficiently provides a counter force against the tissue wall 804 at theentrance of the CS vessel, may provide for greatly improving thedownsizing effect. Since the proximal expandable portion 101 may beshaped and adapted for positioning against the tissue wall 804 at theentrance of the CS, and not inside the CS itself it also reduces therisk of damaging the CS. Also, since the proximal expandable portion 101may be positioned outside the CS it is not constrained by the size ofthe CS and can thus be reversibly expanded to a diameter that spreadsthe force over a larger portion, thus reducing the pressure on thetissue. This also reduces risk of damages.

As schematically illustrated in FIG. 4 d , the distal anchoring portion102 may comprise a balloon 103 having a lumen 104 in the longitudinaldirection of the CS device, which corresponds to the longitudinaldirection of the CS vessel. The method 200 may comprise inflating 229the balloon 103 to secure the position of the balloon 103 in a distalportion of the CS, and providing 230 fluid communication between thedistal region of the CS and a proximal region thereof. Thus, it ispossible to let blood flow through the balloon 103, which improve thesafety of the procedure, while achieving an anchoring effect in the CSvessel.

The present invention has been described above with reference tospecific embodiments. However, other embodiments than the abovedescribed are equally possible within the scope of the invention. Thedifferent features and steps of the invention may be combined in othercombinations than those described. The scope of the invention is onlylimited by the appended patent claims. More generally, those skilled inthe art will readily appreciate that all parameters, dimensions,materials, and configurations described herein are meant to be exemplaryand that the actual parameters, dimensions, materials, and/orconfigurations will depend upon the specific application or applicationsfor which the teachings of the present invention is/are used.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

1. A kit comprising an implant delivery catheter for repairing adefective heart valve and an implant, wherein the implant deliverycatheter comprises: a first part configured to be arranged on aventricular side of the heart valve, wherein the first part isconfigured to form a first curve around chordae of the heart valve onthe ventricular side and a second part configured to be arranged on anatrial side of the heart valve, wherein the second part is configured toform a second curve along an annulus of the heart valve on the atrialside so that the first curve and the second curve form a helix shapewith two continuously connected loops, on opposite sides of the heartvalve, being connected through a commissure of the heart valve; whereinthe implant is configured to be arranged in the delivery catheter and tobe ejected from the delivery catheter while retracting the deliverycatheter such that the implant is arranged along the first and secondcurve on the ventricular and atrial side when retracting the deliverycatheter; wherein the implant has a predefined ring-shape having acurvature corresponding substantially to the first and second curve suchthat, when ejected from the delivery catheter, the implant is arrangedalong the first and second curve; and wherein the predefined ring-shapeis a helix-shaped ring, whereby a first support ring of the helix-shapedring is positioned on the atrial side and a second support ring of thehelix-shaped ring is positioned on the opposite ventricular side whenejected from the delivery catheter, whereby leaflets of the heart valveare pinched between the first and second support rings.
 2. The kitaccording to claim 1, wherein the implant delivery catheter isconfigured to be inserted through the commissure of the heart valve. 3.The kit according to claim 1, wherein the first and second curve of theimplant delivery catheter is configured to be aligned in the plane ofthe heart valve, such that the implant is positioned generally in saidplane when retracting the delivery catheter.
 4. The kit according toclaim 1, wherein the annuloplasty implant is configured to retain amodified shape of the annulus.
 5. The kit according to claim 1, whereinthe annuloplasty implant is configured to be decoupled from the deliverycatheter.
 6. The kit according to claim 1, wherein the implant isconfigured to assume an elongated configuration when confined in thedelivery catheter and to assume the predefined shape when ejected fromthe delivery catheter.
 7. The kit according to claim 1, wherein theshape of the first curve is different from the shape of second curvewhen positioned on the opposite sides of the heart valve.